FDA has approved a supplemental New Drug Application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable heptocellular carcinoma. Nexavar (Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals) is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival.
ROCKVILLE, MarylandFDA has approved a supplemental New Drug Application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable heptocellular carcinoma. Nexavar (Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals) is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival.
The FDA decision closely followed the European Commission's authorization of Nexavar for treatment of HCC.
"The approval of Nexavar in liver cancer marks the second time in 2 years that this novel kinase inhibitor has been granted FDA approval on a priority review basis," said Arthur Higgins, chairman of the executive committee of Bayer Healthcare, referring to the agent's 2005 approval for advanced kidney cancer.
HCC is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. Although HCC is more common in Asia, there are about 19,000 cases in the United States each year, and nearly 17,000 deaths, according to American Cancer Society estimates. In the United States, the 5-year survival rate for liver cancer is 11%. Unresectable disease is usually fatal within 3 to 6 months.
James L. Boyer, MD, chair of the board of directors of the American Liver Foundation commented: "This new treatment provides a valuable option for liver cancer patients and will enable ALF to further promote the treatment of liver disease through our education and advocacy efforts."
Bayer Healthcare and Onyx are providing a patient support program, Resources for Expert Assistance and Care Helpline (REACH), to answer questions about Nexavar treatment, reimbursement, and patient support (1-866-639-2827).
Nexavar, a multi-targeted tyrosine kinase inhibitor, targets both tumor cell and tumor vasculature, which is an advantage "because HCC is one of the most vascular tumors known," Philip James Johnson, MD, of the University of Birmingham, UK, commented at ASCO 2007 where the pivotal study of Nexavar in HCC was presented.
The international phase III SHARP study showed that Nexavar improved overall survival in patients with previously untreated advanced HCC by 44% (HR 0.69, P = .0006), compared with placebo. Median overall survival was 10.7 months for Nexavar vs 7.9 months for placebo, an outcome "most physicians would consider a significant improvement," Dr. Johnson said.
The incidence of grade 3-4 adverse events was 45% for Nexavar vs 32% for placebo. The most common adverse events with Nexavar were diarrhea, fatigue, weight loss, anorexia, nausea, and hand-foot skin reaction. Hypertension may occur early in the course of therapy, and blood pressure should be monitored weekly during the first 6 weeks.
Nexavar is available in 200 mg tablets; the usual dose is two tablets (400 mg) twice daily on an empty stomach.